Duns Number:388240673
Device Description: Determination of ristocetin co-factor activity of von Willebrand factor in human plasma th Determination of ristocetin co-factor activity of von Willebrand factor in human plasma through platelet agglutination
Catalog Number
OUBD39
Brand Name
BC von Willebrand Reagent
Version/Model Number
10714565
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K972116,K972116
Product Code
GGP
Product Code Name
TEST, QUALITATIVE AND QUANTITATIVE FACTOR DEFICIENCY
Public Device Record Key
97bc67ac-01c5-4f4d-9138-070c06617709
Public Version Date
November 18, 2021
Public Version Number
5
DI Record Publish Date
September 24, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 25 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 101 |